Open only to full-conference registrants with a badge. Collect your ticket at the Solutions Circle check-in desk at least 15 min before session start. First-come, first-served seating; standby tickets issued when full. Seats held for 3 minutes after start time.
Head of certification IVD TUV SUD munich, Bayern, Germany
Description: Regulation EU 2017/746 on in vitro diagnostic (IVD) medical devices (IVDR) has either increased or introduced new requirements for IVD medical devices in several areas such as the performance evaluation, rule-based classification system, post market surveillance requirements. It also introduced more prescriptive requirements concerning the definition of the device's intended purpose.
The aim of this solution circle is to give manufacturers the opportunity to ask questions to NB representatives on their expectations regarding post-market surveillance and post-market performance follow-up under the IVDR. After a brief introduction of the topic, participants will be encouraged to ask their questions for an open discussion with NB representatives and industry peers.
Participants will be reminded that NB are not allowed to consult and therefore the discussions will focus on what are the requirements and the expectations rather than how the implementation should occur.
Focus of the discussion: IVDR requirements related Post-Market Surveillance (PMS) and Post-Market Performance Follow-up (PMPF)
Learning Objectives:
Upon completion, participants will have a clear understanding of the IVDR requirements and NB expectations concerning device intended purpose and classification.
Upon completion, participants will have a clear understanding of the IVDR requirements and NB expectations concerning PMS and PMPF.
Upon completion, participants will be able to implement PMS and PMPF requirements.
